December 11, 2012
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Ursodeoxycholic acid improves liver test results, pruritus in patients with intrahepatic cholestasis of pregnancy

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Patients with intrahepatic cholestasis of pregnancy treated with ursodeoxycholic acid experienced reduced pruritus, improved alanine aminotransferase and better fetal outcomes compared with controls and placebo recipients in a recent study.

Researchers performed a systematic review of nine randomized controlled trials (n=454 patients) on the efficacy of ursodeoxycholic acid (UDCA) in patients with intrahepatic cholestasis of pregnancy (ICP). Evaluated factors included the benefits of UDCA to alanine aminotransferase (ALT) and bile acid levels, as well as to pruritus and fetal outcomes, compared with those of placebo and several controls. Across all studies, 207 patients received UDCA alone, 70 received placebo, 42 received cholestyramine, 36 received dexamethasone for 1 week and then placebo for 2 weeks, 65 received S-adenosyl-methionine, and 34 patients underwent no treatment.

Results from pooled analyses indicated significant associations between UDCA use and pruritus resolution compared with controls (OR=0.23, 0.07-0.74) and between UDCA and pruritus reduction compared with controls (OR=0.27, 0.13-0.55) and placebo (OR=0.21, 0.07-0.62) (95% CI for all).

Patients receiving UDCA were more likely than controls or patients receiving placebo to experience normalization (OR=0.23, 0.10-0.50 compared with controls; OR=0.18, 0.06-0.52 compared with placebo) or reduction of serum ALT levels (OR=0.24, 0.11-0.52 compared with controls; OR=0.12, 0.05-0.31 compared with placebo). UDCA also was associated with a reduction of bile acid (OR=0.37, 0.19-0.75 compared with controls; OR=0.30, 0.12-0.73 compared with placebo) (95% CI for all).

Infants born to UDCA recipients with ICP were at reduced risk for premature birth (OR=0.44, 0.24-0.79), fetal distress (OR=0.46, 0.25-0.86) and respiratory distress syndrome (OR=0.30, 0.12-0.74) compared with controls (95% CI for all). No significant differences were observed between UDCA and placebo for these factors. Investigators also noted that no significant difference was observed in the risk for adverse events among patients receiving UDCA and either controls (P=.53) or patients assigned placebos (P=.76).

“Our study provides three relevant findings,” the researcher wrote. “It demonstrates that UDCA is efficient for improving pruritus and liver tests in women with ICP; it provides specific analyses on fetal outcome that strongly suggest a benefit of UDCA; and it confirms the good safety profile of UDCA. This systematic review supports the use of UDCA as initial treatment in patients with ICP.”